Feasibility of self-collection of fecal specimens by randomly sampled women for health-related studies of the gut microbiome

Heather Spencer Feigelson, Kimberly Bischoff, Mary-Anne E Ardini, Jacques Ravel, Mitchell H Gail, Roberto Flores, James J Goedert, Heather Spencer Feigelson, Kimberly Bischoff, Mary-Anne E Ardini, Jacques Ravel, Mitchell H Gail, Roberto Flores, James J Goedert

Abstract

Background: The field of microbiome research is growing rapidly. We developed a method for self-collection of fecal specimens that can be used in population-based studies of the gut microbiome. We conducted a pilot study to test the feasibility of our methods among a random sample of healthy, postmenopausal women who are members of Kaiser Permanente Colorado (KPCO). We aimed to collect questionnaire data, fecal and urine specimens from 60 women, aged 55-69, who recently had a normal screening mammogram. We designed the study such that all questionnaire data and specimens could be collected at home.

Results: We mailed an invitation packet, consent form and opt-out postcard to 300 women, then recruited by telephone women who did not opt-out. Verbally consented women were mailed an enrollment package including a risk factor questionnaire, link to an online diet questionnaire, specimen collection kit, and instructions for collecting stool and urine. Specimens were shipped overnight to the biorepository. Of the 300 women mailed an invitation packet, 58 (19%) returned the opt-out postcard. Up to 3 attempts were made to telephone the remaining women, of whom 130 (43%) could not be contacted, 23 (8%) refused, and 12 (4%) were ineligible. Enrollment packages were mailed to 77 women, of whom 59 returned the risk factor questionnaire and specimens. We found no statistically significant differences between enrolled women and those who refused participation or could not be contacted.

Conclusions: We demonstrated that a representative sample of women can be successfully recruited for a gut microbiome study; however, significant personal contact and carefully timed follow-up from the study personnel are required. The methods employed by our study could successfully be applied to analytic studies of a wide range of clinical conditions that have been postulated to be influenced by the gut microbial population.

Figures

Figure 1
Figure 1
BRanCH Study Overview showing roles of collaborative partners and enrollment activities. NCI: National Cancer Institute; IGS: Institute for Genome Sciences at the University of Maryland School of Medicine; RTI: RTI International.
Figure 2
Figure 2
Enrollment cascade and response rate.

References

    1. Key T, Appleby P, Barnes I, Reeves G. Endogenous sex hormones and breast cancer in postmenopausal women: reanalysis of nine prospective studies. J Natl Cancer Inst. 2002;94(8):606–616. doi: 10.1093/jnci/94.8.606.
    1. Eliassen AH, Missmer SA, Tworoger SS, Hankinson SE. Endogenous steroid hormone concentrations and risk of breast cancer: does the association vary by a woman’s predicted breast cancer risk? J Clin Oncol. 2006;24(12):1823–1830. doi: 10.1200/JCO.2005.03.7432.
    1. Key TJ, Appleby PN, Reeves GK, Roddam AW, Helzlsouer KJ, Alberg AJ, Rollison DE, Dorgan JF, Brinton LA, Overvad K, Kaaks R, Trichopoulou A, Clavel-Chapelon F, Panico S, Duell EJ, Peeters PH, Rinaldi S, Fentiman IS, Dowsett M, Manjer J, Lenner P, Hallmans G, Baglietto L, English DR, Giles GG, Hopper JL, Severi G, Morris HA, Hankinson SE, Tworoger SS. et al.Circulating sex hormones and breast cancer risk factors in postmenopausal women: reanalysis of 13 studies. Br J Cancer. 2011;105(5):709–722. doi: 10.1038/bjc.2011.254.
    1. Raftogianis R, Creveling C, Weinshilboum R, Weisz J. Estrogen metabolism by conjugation. J Natl Cancer Inst Monogr. 2000;27:113–124.
    1. Heimer GM, Englund DE. Enterohepatic recirculation of oestriol: inhibition by activated charcoal. Acta Endocrinol (Copenh) 1986;113(1):93–95.
    1. Heimer GM, Englund DE. Enterohepatic recirculation of oestriol studied in cholecystectomized and non-cholecystectomized menopausal women. Ups J Med Sci. 1984;89(2):107–115. doi: 10.3109/03009738409178470.
    1. Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005;308(5728):1635–1638. doi: 10.1126/science.1110591.
    1. Wagner EH, Greene SM, Hart G, Field TS, Fletcher S, Geiger AM, Herrinton LJ, Hornbrook MC, Johnson CC, Mouchawar J, Rolnick SJ, Stevens VJ, Taplin SH, Tolsma D, Vogt TM. Building a research consortium of large health systems: the Cancer Research Network. J Natl Cancer Inst Monogr. 2005;35:3–11.
    1. Block G, Hartman AM, Naughton D. A reduced dietary questionnaire: development and validation. Epidemiology. 1990;1(1):58–64. doi: 10.1097/00001648-199001000-00013.
    1. Kolonel LN, Henderson BE, Hankin JH, Nomura AM, Wilkens LR, Pike MC, Stram DO, Monroe KR, Earle ME, Nagamine FS. A multiethnic cohort in Hawaii and Los Angeles: baseline characteristics. Am J Epidemiol. 2000;151(4):346–357. doi: 10.1093/oxfordjournals.aje.a010213.
    1. Gren L, Broski K, Childs J, Cordes J, Engelhard D, Gahagan B, Gamito E, Gardner V, Geisser M, Higgins D, Jenkins V, Lamerato L, Lappe K, Lowery H, McGuire C, Miedzinski M, Ogden S, Tenorio S, Watt G, Wohlers B, Marcus P. Recruitment methods employed in the prostate, lung, colorectal, and ovarian cancer screening trial. Clin Trials. 2009;6(1):52–59. doi: 10.1177/1740774508100974.
    1. Lamerato LE, Marcus PM, Jacobsen G, Johnson CC. Recruitment in the prostate, lung, colorectal, and ovarian (PLCO) cancer screening trial: the first phase of recruitment at Henry Ford Health System. Cancer Epidemiol Biomarkers Prev. 2008;17(4):827–833. doi: 10.1158/1055-9965.EPI-06-0528.
    1. Morton LM, Cahill J, Hartge P. Reporting participation in epidemiologic studies: a survey of practice. Am J Epidemiol. 2006;163(3):197–203.
    1. Relman DA. Microbial genomics and infectious diseases. N Engl J Med. 2011;365(4):347–357. doi: 10.1056/NEJMra1003071.
    1. Plottel CS, Blaser MJ. Microbiome and malignancy. Cell Host Microbe. 2011;10(4):324–335. doi: 10.1016/j.chom.2011.10.003.

Source: PubMed

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